FDA likely to end blanket ban on sexually active gay men donating blood
Research backed by the Food and Drug Administration "will likely support" ending a blanket ban on blood donations from sexually active gay men, the agency said Wednesday. The move would mark a significant reversal of a measure aimed at curbing the spread of HIV that experts and activists have long criticized as overly broad and misguided.
Current federal rules prohibit blood banks from collecting donations from men who have had sex with men within the last three months. An alternative approach researched in the FDA-funded ADVANCE study tested out relying on questionnaires to screen donors, instead of broad "time-based deferrals."
"Although we do not have a specific timeline for when our analysis will be complete, the agency believes the initial data from the study, taken in the context of other data available from blood surveillance in the U.S. and in other countries, will likely support a policy transition to individual risk-based donor screening questions for reducing the risk of HIV transmission," the FDA's Carly Kempler said in a statement.
Kempler said the FDA had not yet determined when and how the study's results would be published. The agency is working on draft guidance to be released "in the coming months" that would incorporate results from the study and other "international developments in donor deferral policies."
Several countries have already shifted away from broad waiting periods for gay men to narrower screening approaches, including Canada earlier this year.
"We have highly relevant information to envision what an individual risk-based approach would look like," Vitalant Research's Brian Custer, the study's principal investigator, told The Wall Street Journal, which was first to report news of the looming change.
While donated blood can be tested for HIV, it can be difficult for most blood banks to detect the virus during the early "window period" after infection.
Volunteers for the study answered questions aimed at judging their personal risk of being infected by HIV, and then donated blood samples that were sent off to research laboratories to look for signs of the virus and for pre-exposure prophylaxis drugs, which are taken to reduce the risk of contracting the virus that causes AIDS.
It is unclear what exact questions would be used in the FDA's required screening. Nick Gehrig, a spokesperson for the Vitalant Research Institute which helped lead the study, declined to provide specifics on what questions were trialed.
"The ADVANCE Study is examining if different questions could be added to the donor history questionnaire that are based on individual risk of HIV infection, and if these questions would be as effective as a time-based deferral," Gehrig said.
An end to a rule from the 1980s
A ban on blood donations from men who have sex with men was first imposed in the 1980s, in the early days of the HIV/AIDS epidemic, when much less was known about the virus and treatment options did not yet exist. The FDA first moved in 2014 to loosen the lifelong ban, and a year later switched to a one year "deferral period" since they last had sex, before they could donate.
As the COVID-19 pandemic swelled in 2020, the FDA shortened the deferral period down to 3 months. The agency said it hoped that would alleviate an "urgent and immediate" shortage of blood.
But the regulator has faced continued calls to end the ban altogether, sharpened by a "first-ever blood crisis" declared by the American Red Cross earlier this year. Even before the pandemic, federal authorities had found that supply and demand of blood had been narrowing. In 2019, a years-long slowdown in the use of blood supplies appears to have ended, while blood collections continued to decline.
"America's Blood Centers strongly supports a safe and available blood supply that treats all potential donors with fairness, equality, and respect," Kate Fry, CEO of America's Blood Centers, said in a statement.
The group is one of several that have recently renewed their call for the FDA to change the policy, including GLAAD, the American Medical Association, and several state health officials.
"ABC strongly supports this effort as a pathway to the establishment of donor-screening based on individual risk behaviors, not sexual or gender identity. The use of rational, science-based deferral periods must be applied fairly and consistently among all blood donors," said Fry.